Conditional Approval System of Health Technology (Shear Wave Elastography for Prostate)

OBJECTIVES: This study aims to ascertain whether supplemental shear wave elastography tests, when administered alongside conventional biopsy procedures for suspected prostate cancer, can enhance the detection rate of malignancies. Additionally, the study endeavors to validate the effectiveness of shear wave elastography as an adjunctive diagnostic tool, with the intent to minimize unnecessary biopsies, discern malignant lesions, and reduce their overall quantity.

METHODS: Conducted between December 2020 and December 2022 across three hospitals in Korea, this prospective, multicenter, randomized, double-blind comparative study enrolled 170 subjects meeting specific selection/exclusion criteria. Stratified block randomization, based on prostate-specific antigen (PSA) levels and age, allocated participants to either the 'conventional ultrasound examination' control group or the 'conventional ultrasound examination and prostate shear wave elastography' intervention group. An interim analysis was conducted after recruiting 90 individuals, with 45 in each group.

RESULTS: Among the full analysis set (N=90), the interim analysis revealed a cancer detection rate of 35% (15 cases) in the control group compared to 62% (29 cases) in the test group. However, the observed difference in cancer detection rates did not reach statistical significance (p=0.005), thereby failing to reject the null hypothesis. A safety analysis of 93 individuals within the safety set indicated no statistically significant disparity between the groups (p=0.525). Reported sensitivity and specificity in the test and control groups were 81.5% vs. 54.2% and 65.0% vs. 89.5%, respectively.

CONCLUSIONS: The findings presented herein represent interim analysis results. Caution is advised in interpreting these outcomes, as the final analysis results, pending future evaluation, will provide a more conclusive understanding of shear wave elastography's role in prostate cancer diagnosis.